JOURNEY 74022125Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00885556170410), received between Jun 13, 2017 and Apr 8, 2026 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K111711, K230653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 19, 2022Class IITerminated

   It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

   Z-1099-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A TIGHT KNEE WITH A FLEXION DEFORMITY (FFD). THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE JRNY II BCS FEMORAL OXIN LT SZ 5 WAS REVISED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 24824379 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY (TKA) PERFORMED ON (B)(6) 2016 WHERE A JRNY II BCS FEMORAL OXIN LT SZ 5 WAS IMPLANTED, THE PATIENT EXPERIENCED MIDFLEXION INSTABILITY. THE PATIENT REPORTED A LACK OF TRUST IN THE KNEE DURING STAIR CLIMBING DUE TO A SENSATION OF THE KNEE GIVING WAY. IT IS UNKNOWN HOW THIS ADVERSE EVENT HAS BEEN ADDRESSED. HOWEVER, THE PATIENT RECEIVED MEDICATION. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21997715 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2021, DUE TO END-STAGE OA LEFT KNEE AND IN WHICH JOURNEY II SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUFFERED ON (B)(6) 2021 FROM SUPERFICIAL SURGICAL SITE INFECTION, BLISTERS AND REDNESS THAT REQUIRED KEFLEX X7D PRESCRIBED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21547187 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED SIGNIFICANT VOMIT AND NAUSEA (FROM OXYCODONE-PCA) AND MILD WOUND-OOZE AT DAY 1 POST OPERATION WITH TWO SMALL BLISTERS. DISCHARGE ON (B)(6) 2023. LATER, PATIENT WAS RE-ADMITTED ON (B)(6) 2023 FOR WOUND-OOZE OBSERVATIONS AND DISCHARGE ON (B)(6) 2023 AFTER NO WOUND-OOZE FOR PAST 24 HOURS. NO CHANGES TO MEDICATION. PATIENT IS RECOVERING.

  Patient problems: Blister; Fluid Discharge; Nausea; Vomiting

  MAUDE report 17785464 ↗
• InjuryJul 13, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN AND SUBLUXATION FROM (B)(6) 2018, WHICH WAS UNRESOLVED AT FOLLOW UP ON 14-JUN-2021. THE PATIENT WILL MOST LIKELY BE OFFERED REVISION SURGERY.

  Patient problems: Pain; Subluxation

  MAUDE report 12164356 ↗
• MalfunctionMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD REPEATED ISSUES WITH JII FEMUR PACKAGING. THE INNER PACKAGE, ON SEVERAL OCCASIONS, HAS BEEN STUCK TO THE OUTER PACKAGING MAKING IT IMPOSSIBLE FOR THE NURSE TO DROP THE IMPLANT INTO THE STERILE FIELD. THIS REQUIRES THE INNER PACKAGE TO BE OPENED OFF THE FIELD AND THE ¿NAKED¿ IMPLANT PASSED TO THE FIELD. THIS ADDED LESS THAN A MINUTE DELAY. THE IMPLANTS WERE EVENTUALLY SAFELY PASSED TO THE STERILE FIELD AND IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9902884 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE REQUIRING SUBSEQUENT ARTHROSCOPY.

  Patient problems: Injury

  MAUDE report 9485272 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE ARTHROFIBROSIS AND REQUIRED MANIPULATION UNDER ANESTHESIA AND ASPIRATION.

  Patient problems: Fibrosis

  MAUDE report 8834589 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD CELLULITIS IN LEFT LEG AND A SURGICAL PROCEDURE WAS REQUIRED TO RESOLVE IT.

  Patient problems: Cellulitis

  MAUDE report 8834587 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED, 2-4 WEEKS POST OPERATIVE, PATIENT WAS IN REHAB AND WHEN REACHING FOR WALKER TO GET UP OFF TOILET HEARD A CRACKING SOUND. HER DISTAL FEMUR BROKE ABOVE THE FEMORAL COMPONENT, PATIENT WAS HOSPITALIZED, THE IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER BLOCKS WERE IMPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8660944 ↗
• InjuryApr 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) STUDY; SUBJECT: (B)(6). IT WAS REPORTED THAT PATIENT HAD AN INFECTION TKA LEFT FOR WHICH A REVISION SURGERY WAS REQUIRED.

  Patient problems: Unspecified Infection

  MAUDE report 8547233 ↗
• InjuryFeb 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DUE TO CONTINUED PAIN AND STIFFNESS A REVISION SURGERY WAS PERFORMED TO REMOVE FEMORAL COMPONENT, TIBIAL BASE, TIBIAL INSERT AND PATELLAR COMPONENT.

  Patient problems: Pain

  MAUDE report 8364670 ↗
• MalfunctionDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON THE PATIENT DUE TO INCREASED PAIN AND REDUCED RANGE OF MOTION. NO INSTABILITY IDENTIFIED, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 8197615 ↗
• InjuryOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2017 DOCTOR ELECTED TO ASPIRATE 10CC OF BLOOD-TINGED FLUID ON FROM PATIENT'S KNEE JOINT, 12 DAYS LATER DOCTOR INJECTED 20.5MCI OF TC 99M HDP DUE TO PAIN AND SWELLING.

  Patient problems: Pain; Swelling

  MAUDE report 7950199 ↗
• InjuryOct 1, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE POOR RANGE OF MOTION AND EXPERIENCING MORE PAIN THAN EXPECTED. AN ASPIRATION WAS PERFORMED TO RULE OUT INFECTION.

  Patient problems: Injury; Muscular Rigidity; Pain

  MAUDE report 7924165 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT AS SHE DEVELOPED ARTHROFIBROSIS.

  Patient problems: Fibrosis; Pain

  MAUDE report 7924139 ↗
• InjurySep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7882316 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CONDYLE METAPHYSEAL COMPRESSION FRACTURE CONSISTENT WITH KNEE PAIN AND DIFFICULTY WALKING.

  Patient problems: Bone Fracture(s)

  MAUDE report 7148986 ↗
• InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  FOLLOWING RECEIPT OF ADDITIONAL INFORMATION CONCERNING THIS CASE IT HAS BEEN DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR. PLEASE THEREFORE DISREGARD THIS REPORT.

  Patient problems: Pain

  MAUDE report 7102230 ↗
• InjuryOct 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO KNEE ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 6986928 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION, INFLAMMATION REACTION TO PROSTHESIS, ILIOTIBIAL BAND TENDINITIS AND NON-HEALING SURGICAL WOUND DUE TO A TOTAL KNEE ARTHROPLASTY.

  Patient problems: Unspecified Infection

  MAUDE report 6936816 ↗
• InjuryOct 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO LEFT KNEE SWELLING, WAS POSITIVE FOR DVT AND WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Injury; Swelling

  MAUDE report 6928156 ↗
• InjuryAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS PLACED IN THE HOSPITAL DUE TO CELLULITIS OF THE KNEE. CELLULITIS OF KNEE WAS REPORTED. SUBJECT WAS HOSPITALIZED AND WAS GIVEN METRONIDAZOLE AND CIPRO.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6778167 ↗
• InjuryJul 7, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH RETROSPECTIVE CLINICAL TRIAL THAT PATIENT UNDERWENT OTHER CONSERVATIVE APPROACH PROCEDURE IN ORDER TO SOLVE POST TKA ARTHROFIBROSIS OF THE LEFT KNEE. EVENT WAS RESOLVED ON (B)(6) 2012 AND ITS SEVERITY WAS DEEMED TO BE MILD.

  Patient problems: No Information

  MAUDE report 6693279 ↗
• InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO US THROUGH RETROSPECTIVE CLINICAL TRIAL THAT PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY (KEFLEX 500 MG, 4 X 1) TO SOLVE INCISION INFECTION OF LEFT KNEE. OUTCOME IS RESOLVED AND SEVERITY OF THIS EVENT WAS DEEMED MILD. STUDY INVESTIGATOR DEEMED THIS EVENT AS POSSIBLY RELATED TO PROCEDURE AND UNRELATED TO STUDY DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6688997 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint